hfpef and symptomatic obstructive iliofemoral venous disease study

Conditions: Heart Failure With Preserved Ejection Fraction; Venous Disease

Summary: to ascertain the potential symptom improvement assessed by cardiopulmonary exercise testing (cpet) in subjects with heart failure with preserved ejection fraction (hfpef) and nonthrombotic iliofemoral venous lesions and/or iliocaval obstruction defined by mr or ct venography and ceap clinical category ≥3 prior to venous stenting.

primary objective: evaluate potential improvement in metrics of functional capacity assessed by cardiopulmonary exercise testing performed before and after venous stenting of an ≥50% iliofemoral venous obstruction by mr or ct venography and confirmed by intra-procedural ivus in a prospective patient cohort presenting with heart failure with preserved ejection fraction with a h2fpef score of ≥4 and a ceap category ≥3. secondary objectives: identify patient demographic, baseline laboratory, imaging, procedural and cardiopulmonary exercise testing variables and the fda-approved minnesota living with heart failure questionnaire as a medical device development tool (mddt) in patients with and without functional improvement as assessed by cardiopulmonary exercise testing vo2max after successful venous stenting of iliofemoral/iliocaval venous obstructions.

Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent and comply with all study requirements * age ≥ 40 years of age * stable, symptomatic heart failure with preserved ejection fraction and a h2fpef score ≥4 * presence of non-malignant inferior vena cava obstruction, a unilateral or bilateral chronic non-malignant obstruction of the common femoral vein, external iliac vein, common iliac vein, or any combination thereof, defined as a ≥50% reduction in target vessel lumen diameter defined by screening mrv, ctv and confirmed by a 50% reduction in luminal area as assessed by intraprocedural ivus. * previous (\>6 months) history of ilio-femoral and/or lower extremity deep venous thrombosis associated with a residual ilio-femoral venous obstruction ≥50% by mrv, ctv. * clinically significant venous obstruction meeting ceap clinical classification ≥3. * negative pregnancy test in females of child-bearing potential exclusion criteria: * subject hospitalized for acute compensated heart failure within 60 days prior to enrollment * presence of history of clinically significant pulmonary emboli within 6 months prior to enrollment. * subject has any permanent neurologic defect that may cause non-compliance with the protocol * subject has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematous). * subject has an allergy to contrast media that cannot be adequately pre-treated prior to the required diagnostic and/or endovascular procedures. * subject has an active peptic ulcer or active gastrointestinal (gi) bleeding. * subject has renal failure or chronic kidney disease with glomerular filtration rate (gfr) ≤ 30 ml/min or modification of diet in renal disease (mdrd) study equation result of ≤ 30 ml/min per 1.73 m2. * subject has white blood cell (wbc) count \< 3.0 (3000 cells/mm3) within 7 days prior to index procedure. * subject has a platelet count \ 700,000 cells/mm3 ≤ 7 days pre procedure; uncorrected hemoglobin of ≤9 g/dl. * subject has known or suspected active systemic infection evidenced by wbc \> 14.0 (14,000/mm3). * subject is currently participating in another investigational drug or device study. * subject intends to participate in another investigational drug or device study within 30 days after the index procedure. * subject has moderate or severe pulmonary disease (i.e., copd) considered by investigator to be a major contributing factor to the subject's exertional dyspnea